APO-OXYBUTYNIN TABLET
国家: 加拿大
语言: 英文
来源: Health Canada
产品特点
(SPC)
24-01-2022
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有效成分:
OXYBUTYNIN CHLORIDE
可用日期:
APOTEX INC
ATC代码:
G04BD04
INN（国际名称）:
OXYBUTYNIN
剂量:
5MG
药物剂型:
TABLET
组成:
OXYBUTYNIN CHLORIDE 5MG
给药途径:
ORAL
每包单位数:
100 & 500 TABLETS
处方类型:
Prescription
治疗领域:
Antimuscarinics
產品總結:
Active ingredient group (AIG) number: 0114692001; AHFS:
授权状态:
APPROVED
授权日期:
2022-01-25
产品特点
Page 1 of 23
PRODUCT MONOGRAPH
PR
APO-OXYBUTYNIN
Oxybutynin Chloride Tablets 5 mg, USP
PR
APO-OXYBUTYNIN
Oxybutynin Chloride Syrup 1 mg / mL, USP
ANTICHOLINERGIC / ANTISPASMODIC AGENT
APOTEX INC.
150 Signet Drive
Weston, Ontario
M9L 1T9 DATE OF PREPARATION:
April 18,1995 DATE OF REVISION:
January 24, 2022
Submission Control number #259986
Page 2 of 23
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..............................................................................
3
SUMMARY PRODUCT INFORMATION
...............................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................................
3
CONTRAINDICATIONS
......................................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................................
4
ADVERSE REACTIONS
.......................................................................................................................
6
DRUG INTERACTIONS
......................................................................................................................
8
DOSAGE AND ADMINISTRATION
....................................................................................................
9
OVERDOSAGE
.................................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
10
STORAGE AND STABILITY
...............................................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................................................................
12
PART II: SCIENTIFIC INFORMATION
.........................................................................
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